Ivenix, Inc. recallZ-1484-2024 · Fresenius Kabi USA, LLC · initiated Mar 7, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Kabi USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
FDA root cause category: Software Design Change
What the company is doing
A letter titled URGENT - Medical Device Field Correction, dated 3/7/24, was delivered by hand to consignees or by mail notifying them of this recall event. This notice details eleven software anomalies that could pose a potential risk of serious patient harm or death and the mitigations consignees should perform until software is updated. Consignees are to update their software to LVP software version 5.9.1 by reaching out to their Fresenius Kabi representative at 1-978-775-8100 to schedule installation. Consignees are to complete and return the Customer Reply Form via fax or email. Questions about the recall notice can be directed to Fresenius Kabi by email at [email protected] or by phone at 1-978-775-8100 (Monday through Friday from 8:30 am to 5:00 pm).
Recall details
- Recall number
- Z-1484-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 7, 2024
- Posted by the FDA
- Apr 11, 2024
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 17 units
- Product code
- FRN
- FDA submissions
- K183311
- Distribution
- US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
Product description
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Code information (models, lots, serial numbers)
Product LVP-SW-0004; UDI-DI 00811505030122.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ivenix, Inc. 2.0Fresenius Kabi AG · Pump, Infusion10 recalls0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K183311 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Ivenix Infusion System LVP-0004Fresenius Kabi AG · Pump, Infusion7 recalls2 deaths4,328 reports
- Ivenix Infusion System 030-0028-08Fresenius Kabi AG · Pump, Infusion7 reports
- Ivenix Infusion System 030-0027-06Fresenius Kabi AG · Infusion Safety Management Software3 reports
- Ivenix Infusion System 030-0028-07Fresenius Kabi AG · Pump, Infusion2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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